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It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.

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Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).

RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference. Four outstanding individuals will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees will be the first-ever recipients of the Community Leadership Award.

Caribbean Regulatory System Begins Recommending Generic Drugs

The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments.

The recommendations, which follow approval from WHO, included emtricitabine/tenofovir and tenofovir tablets, also known as generic versions of Viread and Truvada (a generic of which also recently won US FDA approval).

The regional initiative is meant to help Caribbean states perform key regulatory functions and is a collaboration between the Caribbean Community and Common Market (CARICOM) and CARPHA, with the support of the Pan American Health Organization/World Health Organization (PAHO/WHO).

Trinidad and Tobago-based Dr. Charles Preston, a PAHO advisor, told Focus in a phone interview that India-based Strides is the manufacturer of the recently recommended medicines, though any manufacturers can apply to introduce their medicines to the 17 million people in the CARICOM market.

CARICOM is made up of 15 member states, some of which have regulators that can be limited in their capacity to assess the safety, quality and efficacy of medicines, including Bahamas, Barbados, Grenada, Haiti, Jamaica, Suriname and Trinidad and Tobago, among others.

The target is to sign off on marketing authorizations within 60 calendar days, which is significantly faster than what the Caribbean countries can muster independently, especially as some do not even have a medicines regulator, and at least one has more than a couple hundred drugs backlogged in its review process, Preston said.

CARPHA/CRS requires that the medicines it examines win prior approval from a trusted regulator, such as FDA, Health Canada or Brazil’s ANVISA, though he said it can still be difficult to get the drugs to market in these countries once they are approved.

Moving forward, as more pharmaceutical companies use CARPHA/CRS, a list of favorably evaluated products will be created, which PAHO says more Caribbean governments can use in their authorization and procurement decisions. Preston noted that CRS recently collaborated with WHO on a workshop to review a couple medicines, and they invited member states that have a registration function.

He also said the eventual goal is to create a user fee-based system for the market, like what's used in the US, with one set of requirements and a faster process, as a lot of countries in the region currently do not have timelines for processing medicines.

Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. View More